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A Study of the Safety of Topiramate Given in Combination With Other Medications in Adults and Children With Seizures.
This study has been completed.
Study NCT00297349   Information provided by Janssen Cilag Pharmaceutica S.A.C.I., Greece
First Received: February 24, 2006   Last Updated: October 19, 2007   History of Changes
This Tabular View shows the required WHO registration data elements as marked by

February 24, 2006
October 19, 2007
November 2003
 
 
Complete list of historical versions of study NCT00297349 on ClinicalTrials.gov Archive Site
 
 
 
A Study of the Safety of Topiramate Given in Combination With Other Medications in Adults and Children With Seizures.
An Open-Label Observation Study Of Topiramate Administration As Adjuvant Therapy For Focal Epilepsy, Lennox-Gastaut Syndrome Epileptic Seizures And Generalized Tonoclonic Seizures In Adults And Children Aged 2 Years And Older.

The purpose of this study is to evaluate the safety of topiramate when used in combination with other medications for seizures in adults and children.

Topiramate is a medication that is approved for the treatment of seizures. In accordance with international guidelines, studies are conducted after a drug is marketed to continue to evaluate and expand the knowledge regarding its safety. This is an open-label, multi-center observational safety study to collect safety information for oral topiramate given in addition to other medications for 3 types of seizures (focal epilepsy, LENNOX-GASTAUT syndrome epileptic seizures and generalized tonic-clonic seizures) in adults and in children aged 2 years and older. Patients whose previous treatment for seizures (one or more antiepileptic drugs) has been judged by their physician to be non-satisfactory will receive 6 months of treatment with topiramate in addition to other antiepileptic medication as prescribed by their physician. Topiramate will be given at low doses initially and gradually increased as necessary to control seizure activity in accordance with Summary of Product Characteristics (SmPC). Patients will be asked to keep a diary of adverse events and seizure activity. Safety evaluations (incidence of adverse events, physical examinations, vital signs and laboratory tests) will be performed throughout the study per investigators daily clinical practice. At the end of the study, the treating physician may continue treatment with topiramate and other medication as appropriate. The study hypothesis is that topiramate given in combination with other antiepileptic medications will be effective in achieving and maintaining control of seizure activity and is well-tolerated.

Individualization of the treatment should begin with administration of the drug in the evening, from 25 mg for one week. Subsequently, every week or every two weeks, the dose should be increased by 25-50 mg/day and be taken in two divided doses. Study duration: 6 Months

Phase IV
Observational
Prospective
  • Epilepsy
  • Seizures
Drug: topiramate
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
165
June 2005
 

Inclusion Criteria:

  • Non-premenopausal female patients using a medically acceptable contraceptive method as discussed with their doctor
  • History of medical records of frequency and the type of seizures during the period prior to inclusion in the study
  • Prior treatment until inclusion in the study with one or more antiepileptic drug treatment judged non-satisfactory by the investigator

Exclusion Criteria:

  • Patients not suffering from epilepsy, whose seizures are due to other causes including disease, exposure to harmful substances, active infection or tumor
  • Patients with a history of generalized status epilepticus (prolonged seizures) within the last three months
  • Patients with progressive brain tumor or other progressive or degenerative disorders
  • Patients with a history (within the previous six months) of mental or emotional disorders requiring shock treatment or major sedation, monoamine oxidase (MAO) inhibitors or medications which affect the central nervous system
  • Patients with any medical or social condition that may affect their ability to take part in study or the safety of the study
  • Patients who cannot take the drug or fill in the diary, either alone or with help. If help is needed, it should be permanently available throughout the study
Both
2 Years and older
No
 
 
 
 
NCT00297349
 
 
Janssen Cilag Pharmaceutica S.A.C.I., Greece
 
Study Director: Janssen-Cilag Pharmaceutica S.A.C.I. Clinical Trial Janssen Cilag Pharmaceutica S.A.C.I., Greece
Janssen Cilag Pharmaceutica S.A.C.I., Greece
October 2007

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.